Here are some reimbursement related reasons why access to biosimilars has been slower than hoped, even though patient out-of-pocket costs are lower. Current System Is an Improvement Over Earlier System, But Could Be Better Part B Is For Biologics (and Some Drugs) When I was working at the Senate Legislative Counsel’s office drafting the Average [...] Read More
This evening, the Centers for Medicare and Medicaid Services (CMS) released the CY 2019 proposed payment rule for the End-Stage Renal Disease (ESRD) program and for Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS). The rule contains a payment update for the ESRD Prospective Payment System, changes to the ESRD quality program, and an expansion […]
Read MoreThis morning, the Senate Health, Education, Labor and Pensions (HELP) Committee held the first congressional hearing on President Donald Trump's plan to combat high drug prices, "American Patients First." The hearing featured testimony from Department of Health and Human Services (HHS) Secretary Alex Azar as well as questions from Committee members. Senators on both sides [...] Read More
President Trump has released his long-awaited plan to address prescription drug prices, the mysterious contents of which have been causing heartburn for manufacturers, pharmacy benefit managers (PBMs), health plans, and other stakeholders for several weeks. The consensus seemed to be that manufacturers and PBMs were likely to have large targets on their backs. On the […]
Read MoreThe Trump Administration has introduced a slate of proposals designed to lower the prices of prescription drugs, mainly those paid for by Medicare and Medicaid, including both physician-administered drugs in Part B and the prescription drug benefit offered in Part D. Many of the proposals are focused on reducing beneficiary out-of-pocket costs rather than lowering […]
Read MoreOn December 27, CMS issued a State Medicaid Director letter to explain new limitations on federal financial participation for durable medical equipment (DME) in Medicaid. Beginning on January 1, 2018 (as required by Section 5002 of the 21st Century Cures Act), federal reimbursement to states for DME expenditures in Medicaid will be limited to the […]
Read MoreOn November 29, 2017, the Senate Health, Education, Labor and Pensions (HELP) Committee held a courtesy hearing to consider the nomination of Alex Azar as Secretary of the U.S. Department of Health and Human Services (HHS). Mr. Azar has been nominated to replace Tom Price, who resigned as Secretary in late September of this year. […]
Read MoreThis morning, The Hill hosted an event, sponsored by the Coalition for Affordable Prescription Drugs, entitled, “The Prescription Drug Delivery System: Tackling Costs, Ensuring Access.” The event featured headliners Senator Bill Cassidy (R-LA), Representative Diana DeGette (D-CO), Representative Gene Green (D-TX), and FDA Commissioner Scott Gottlieb. Other speakers included representatives from trade organizations, manufacturers, and […]
Read MoreOn July 18, 2017, the Food and Drug Administration (FDA) hosted a public meeting entitled, “The Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access.” The meeting was a public opportunity for interested stakeholders to provide the FDA with information and policy recommendations about how to encourage competition while also maintaining access. Much of the […]
Read MoreOn June 13, 2017, the Senate Health, Education, Labor, & Pensions (HELP) Committee held a hearing to discuss the cost of prescription drugs, in particular how the drug delivery system affects what patients pay. The hearing was held after a request from a bipartisan group of senators led by Senators Al Franken (D-MN) and Bill […]
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